The Association Between Problematic Media Use and Postoperative Pain Severity in Pediatric Patients Undergoing Tonsillectomy: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- FLACC pain scores
研究概览
简要总结
This observational study aims to investigate whether problematic media use is associated with postoperative pain severity in children aged 4-11 years undergoing tonsillectomy. A total of 94 parents who consent to participate and have children within the target age range will be included. Data will be collected using a structured questionnaire covering sociodemographic characteristics, family and child media habits, parental attitudes toward screen use, and the Problematic Media Use Scale (PMUS). Postoperative pain will be assessed using the FLACC scale at multiple time points within the first 24 hours after surgery.
详细描述
Parents of children aged 4-11 years who agree to participate will be enrolled (n=94). The data collection form includes sociodemographic characteristics of the child and family, media use habits of both the child and parents, parental attitudes toward screen exposure, and the Problematic Media Use Scale (PMUS). All children will undergo a detailed history, physical examination, and routine hematological and biochemical tests. Children with allergies, recent upper respiratory infections, asthma, chronic obstructive pulmonary disease, or those who have received NSAIDs within the past 24 hours will be excluded.
Tonsillectomy indications include recurrent tonsillitis and/or tonsillar hypertrophy. All patients will undergo bilateral tonsillectomy via classical extracapsular dissection under general anesthesia. Hemostasis will be achieved with bipolar cauterization and packing. Postoperatively, oral intake will be restricted for 4 hours, and all patients will receive identical analgesic management consisting solely of paracetamol (10 mg/kg) administered three times daily.
The Problematic Media Use Scale (PMUS) was developed by Domoff et al. in 2017 for children aged 4-11 years to assess problematic digital media use. The Turkish validation of both the long and short forms was conducted by Furuncu in 2019. Based on DSM-5 Internet Gaming Disorder criteria, the scale includes items scored on a 5-point Likert scale, with higher scores indicating more problematic use. The short form of PMUS will be used in this study.
Participants will be categorized into two groups based on PMUS scores. Pain intensity will be evaluated using the FLACC scale at the 1st, 6th, 12th, and 24th postoperative hours. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), scored 0-2 each, with total scores ranging from 0 to 10. A score of 0 indicates comfort, 1-3 mild discomfort, 4-6 moderate pain, and 7-10 severe pain or distress.
Sample size was calculated based on a Type I error of 0.05, power of 0.80, and an expected correlation coefficient of r = 0.30 (low-level association) between problematic media use and pain score. This yielded a required sample of 85 participants. Accounting for approximately 10% attrition, the study aims to enroll 94 children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-11 years
- •Scheduled for bilateral tonsillectomy
- •Parent/guardian capable of completing questionnaires
- •Parent/guardian willing to provide informed consent
排除标准
- •Allergy, recent cold/upper respiratory infection
- •NSAID use within 24 hours before surgery
- •Any condition impairing pain assessment
- •Refusal of consent
结局指标
主要结局
FLACC pain scores
时间窗: 1, 6, 12, and 24 hours postoperatively
The FLACC (Face, Legs, Activity, Cry, Consolability) scale is a validated behavioral pain assessment tool used in pediatric patients who are unable to self-report pain reliably. It consists of five categories:Face, Legs, Activity, Cry, Consolability. Each category is scored from 0 to 2, resulting in a total score ranging from 0 to 10, where higher scores indicate more severe pain. Scores are interpreted as follows: 0: Relaxed and comfortable 1-3: Mild discomfort 4-6: Moderate pain 7-10: Severe pain or significant distress In this study, FLACC scores will be recorded at 1, 6, 12, and 24 hours postoperatively.
次要结局
未报告次要终点
研究者
Ali Genc
Assistant professor
Tokat Gaziosmanpasa University
